105SAR301: TRC105 and pazopanib vs pazopanib in advanced angiosarcoma
Research type
Research Study
Full title
A RANDOMIZED PHASE 3 TRIAL OF TRC105 AND PAZOPANIB VERSUS PAZOPANIB ALONE IN PATIENTS WITH ADVANCED ANGIOSARCOMA (TAPPAS)
IRAS ID
228745
Contact name
Robin Jones
Contact email
Sponsor organisation
TRACON Pharmaceuticals, Inc.
Eudract number
2016-000485-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Angiosarcoma, a subtype of soft tissue sarcoma, is a rare and aggressive vascular malignancy associated with poor prognosis. About half of these patients present with primary cutaneous lesions (tumor arising from the skin, often consisting of multiple lesions and located in critical areas like head and neck). Risk factors for this presentation include prior radiation exposure as well as inflammatory damage in chronically sun exposed skin.
Current treatment options are limited and of modest benefit. Median overall survival is approximately 8 to 11 months for patients with metastatic disease.
This is a phase 3 study where patients will be treated with TRC105 (the study drug) + Pazopanib or Pazopanib alone. Pazopanib is approved for the treatment of patients with soft tissue sarcoma, including angiosarcoma. In this study patients will be treated until disease progression, intolerable toxicity, patient decision to withdraw or other reason. Patients will undergo radiology assessments every 6 weeks and blood tests and additional safety assessments at each visit when the drugs are administrated.
The study will include patients over 17 years old who meet the eligibility criteria. Patients will be identified and treated in NHS hospitals.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1560
Date of REC Opinion
16 Oct 2017
REC opinion
Further Information Favourable Opinion